News Release

News Release
Media Contacts:
Marie-Christine Garon
Merck
514-428-3445
Montreal
Dominique Quirion
514-843-2302
Toronto
Sarah Bannoff
416-848-9851
Runny nose; sneezing; itchy nose, throat, or eyes; and congestion:
An estimated 20% to 25% of the Canadian population suffer from allergic rhinitis1
RAGWITEK™, AN ALLERGY IMMUNOTHERAPY TABLET FOR THE TREATMENT
OF SIGNS AND SYMPTOMS OF RAGWEED ALLERGY, IS NOW AVAILABLE IN
CANADA
Kirkland, Quebec – May 15, 2014 – A new treatment option is now available for
Canadian allergic rhinitis sufferers. RAGWITEK™ (Standardized Allergen Extract, Short
Ragweed (Ambrosia artemisiifolia) Sublingual Tablet) is an immunotherapy treatment to
help manage ragweed allergies. It is indicated for reducing the signs and symptoms of
moderate to severe seasonal short ragweed pollen induced allergic rhinitis, with or
without conjunctivitis, in adults confirmed by clinically relevant symptoms for at least two
pollen seasons and a positive skin prick test and/or a positive titre to Ambrosia
artemisiifolia specific IgE, and who have responded inadequately, or are intolerant to
conventional pharmacotherapy.2
“Immunotherapy treatment retrains the immune system. By administering a standardized
dose of an allergen we can accustom the body to not react in an allergic way to
allergens such as ragweed pollen”, says Dr. Paul Keith, Allergist / Immunologist,
Associate Professor, Division of Clinical Immunology and Allergy, Department of
Medicine, McMaster University. “Not only have these sublingual immunotherapy tablets
demonstrated excellent safety and efficacy profiles, they also represent a convenient
choice of treatment for our patients”.
Efficacy demonstrated during the first ragweed pollen season
For optimal results, the dosing should be initiated at least twelve weeks before the
ragweed pollen season and maintained throughout this period.3
-more-
-2“It is recommended to start this ragweed sublingual immunotherapy treatment at least
three months prior to the ragweed season and maintain daily dosing throughout the
season. The patient has to place the tablet under the tongue, where it will dissolve in
seconds, and after the first dose taken in the doctor’s office, this can be done at home”,
concludes Dr. Keith.
Adults
RAGWITEK™ has been approved for use in adults with efficacy and safety data
demonstrated in two clinical trials which involved 1349 patients 18 to 50 years of age
with short ragweed pollen-induced rhinoconjunctivitis.4
With this new treatment option, Merck Canada affirms its longtime commitment to
developing respiratory products that provide physicians with a wide range of treatment
options to help their patients suffering from allergies.
About allergies and allergic rhinitis
Caused by the immune system over reacting to a normally harmless substance called an
allergen, allergic rhinitis sufferers can experience symptoms such as sneezing, nasal
congestion, a runny nose, itchiness in the nose, throat, eyes and ears.5
Approximately 20% to 25% of the Canadian population suffers from allergic rhinitis, an
inflammatory disease of the nasal mucous membranes whose prevalence is increasing
worldwide.1 Often starting in childhood and persisting into adult life,6 allergic rhinitis can
have an impact on the sufferers’ social life, school performance, and work productivity.7
About Merck
Today's Merck is a global healthcare leader working to help the world be well. Merck is
known as MSD outside the United States and Canada. Through our prescription
medicines, vaccines, biologic therapies, and consumer care and animal health products,
we work with customers and operate in more than 140 countries to deliver innovative
health solutions. We also demonstrate our commitment to increasing access to
healthcare through far-reaching policies, programs and partnerships. For more
information about our operations in Canada, visit www.merck.ca.
Forward Looking Statement
This website includes "forward-looking statements" within the meaning of the safe harbor
provisions of the United States Private Securities Litigation Reform Act of 1995. These
statements are based upon the current beliefs and expectations of Merck's management
and are subject to significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the necessary regulatory
approvals or that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize, actual results may
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Risks and uncertainties include but are not limited to, general industry conditions and
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Merck undertakes no obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise. Additional factors that
could cause results to differ materially from those described in the forward-looking
statements can be found in Merck's 2012 Annual Report on Form 10-K and the
company's other filings with the Securities and Exchange Commission (SEC) available
at the SEC's Internet site (www.sec.gov).
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The news release is available at www.cnw.ca.
1
Keith, P., Desrosiers, M. et al, 2012. The Burden of Allergic Rhinitis (AR) in Canada: Perspectives of
Physicians and Patients, Allergy, Asthma and Clinical Immunology [Online] Available at:
www.aacijournal.com/content/8/1/7 [Accessed 2014-04-23].
2
RAGWITEK Product Monograph, Merck Canada Inc., April 23, 2014. Page 3
3
RAGWITEK Product Monograph, Merck Canada Inc., April 23, 2014. Page 12
4
RAGWITEK Product Monograph, Merck Canada Inc., April 23, 2014. Page 7
5
American Academy of Allergy Asthma & Immunology, 2013. Allergic Reactions: Tips to Remember [Online]
Available at:
www.aaaai.org/patients/publicedmat/tips/whatisallergicreaction.stm [Accessed 2014-04-23].
6
Allergy/Asthma Information Association, 2008. Allergic Rhinitis [Online] Available at:
www.aaia.ca/en/allergic_rhinitis.htm [Accessed 2014-04-23].
7
Brozek, J. L., Bousquet, J. et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines: 2010
Revision. Journal of Allergy & Clinical Immunology Vol. 126(3), pp. 466-476